Scanlux® 300 (Scanlux® 300)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceYopamidolYopamidol
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  • Scanlux® 300
    solution in / vessel. 
    Sanochemistry Pharmaceuticals AG     Austria
  • Scanlux® 370
    solution in / vessel. 
    Sanochemistry Pharmaceuticals AG     Austria
    • Dosage form: & nbspsolution for intravenous and intraarterial administration
    Composition:

    In 1 ml of the drug contains:

    active substance: yopamidol (in terms of free iodine 300 mg) 612.0 mg;

    Excipients: trometamol 1.0 mg, sodium calcium edetate 0.39 mg, 2.5 M solution of hydrochloric acid to adjust the pH to 6.5-7.5, water for injection to 1.0 ml.

    Description:

    Transparent, from a colorless to slightly yellowish solution.

    Pharmacotherapeutic group:radiopaque
    ATX: & nbsp

    V.08.A.B   Water-soluble low-osmolarity radiopaque substances for the study of the kidneys

    Pharmacodynamics:

    Scanlux® 300 is a nonionic iodine-containing low molecular weight radiocontrast water-soluble preparation. The solution has low osmotic pressure, which contributes to good local and systemic tolerance. It is used as a radiopaque drug for intra-arterial and intravenous administration.

    Pharmacokinetics:

    Yopamidol is not metabolized, not cumulated in the liver and is excreted chemically unchanged by glomerular filtration. The half-life in patients with normal renal function is about 2 hours. After 24 hours yopamidol almost completely eliminated from the body with urine.

    Yopamidol does not penetrate the blood-brain barrier, through the placental barrier - to an extremely small extent. In patients with impaired renal function, the half-life period is prolonged depending on the degree of kidney damage. Yopamidol does not bind to serum or plasma proteins.

    Indications:

    Radiopaque meanstin for peripheral arteriography venogginand, urography, cerebral angiography, coronary angiography, ventriculography, contrast enhancement in computed tomography.

    Contraindications:

    - Hypersensitivity to yopamidol (including to other iodine-containing radiopaque agents), as well as the auxiliary substances that make up the drug;

    - severe thyrotoxicosis;

    - epilepsy;

    - severe cardiovascular failure;

    - multiple myeloma;

    - acute inflammatory diseases of the pelvic organs (for hysterosalpingography);

    - acute pancreatitis (for endoscopic retrograde cholangiopancreatography);

    - Waldenstrom's macroglobulinemia;

    - severe hepatic and / or renal insufficiency.

    Carefully:

    Violation of the kidneys, liver and cardiovascular system, pulmonary emphysema, severe general condition, severe cerebral vascular sclerosis, requiring correction of diabetes mellitus, latent hyperthyroidism, nodular goitre of mild and moderate severity.

    Pregnancy and lactation:

    The drug should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus, and such a study is appointed by the doctor because of its need. During pregnancy, hysterosalpingography is prohibited.

    Radiopaque means are excreted in breast milk to an insignificant degree, therefore, if it is necessary to administer the drug, stop breastfeeding and do not resume at least 24 hours after the test.

    Dosing and Administration:

    Scanelux® is administered intravenously, intra-arterially.

    Types of diagnosis and dose

    When using Scanulux ® 300 (300 mg iodine / ml), the following dosages are recommended:

    Procedure

    Type of research

    The recommended dose

    Peripheral arteriography

    Adults: 20-50 ml *

    Children: 0.5-0.75 ml / kg

    Venography

    Adults: 20-50 ml *

    Children: 0.5-0.75 ml / kg

    Left ventriculography

    Adults: 25 ml

    Children: 0.5-0.75 ml / kg.

    X-ray computed tomography

    Total body scan: 40-100 ml **

    Intravenous urography

    Adults:

    Not more than 1.0 ml / kg body weight

    Children (2-11 years old)

    1.5 ml / kg body weight

    Children (from 1 month to 2 years)

    3.0 ml / kg body weight

    Newborns

    4.0 ml / kg body weight

    * if necessary, repeat the dose.

    ** for adults.

    The total volume of the injected solution should not exceed 250 ml.

    For the elderly, dosage changes are not required.

    Side effects:

    Common Adverse Reactions

    The most frequent: skin hyperemia, dizziness, headache, pain at the injection site, nausea, vomiting, generalized fever, increased sweating, acute rhinitis, laryngeal edema; asthenic syndrome, pallor of the skin, shortness of breath and a moderate decrease in blood pressure. In some cases, fever is noted.

    Allergic reactions in the form of skin rashes (urticaria), itchy skin, Quincke's edema, bronchospasm.

    Rarely heavy hypersensitivity reactions (anaphylactic shock) are noted in patients with a predisposition to allergies, and also taking beta-blockers.

    Reactions are possible from the cardiovascular system, such as peripheral vasodilatation, tachycardia, dyspnea, cyanosis, bradycardia, which require urgent treatment.

    Neurological reactions, such as fainting, confusion, tonic / clonic convulsions, aphasia, temporary narrowing of the visual fields, hemiparesis, coma developed in patients suffering from epilepsy, increased convulsive readiness and other CNS diseases.

    Adverse reactions and warnings in angiographic studies

    Patients undergoing angiographic procedures should pay special attention to the state of the right heart and pulmonary circulation.

    The introduction of an organic iodine-containing solution with a deficiency of the right heart and pulmonary hypertension can cause bradycardia and a decrease in blood pressure.

    When contrasting the aortic arch in a number of cases, it is possible to reduce blood pressure, bradycardia.

    With abdominal aortography there may be a kidney infarction, spinal cord injury, retroperitoneal bleeding, and bowel necrosis.

    When the vessels are catheterized it is necessary to pay special attention to the angiographic technique, since non-ionic radiopaque preparations, in comparison with ionic drugs, have a lower anticoagulant activity in vitro. In this regard, in order to minimize the risk of thromboembolism associated with the procedure, it is necessary to properly install the catheter, wash it with 0.9% sodium chloride solution, if possible with the addition of heparin, and also minimize the duration of the procedure.

    Overdose:

    Overdosing can occur only if there is a marked impairment of kidney function or accidental administration of large doses of the drug. ANDzhousehold daboutThreat etcecouplethat mogut evoke burdenelye complications, especiallybthe with hand cardiovascular, respiratory systems and kidney function.

    Treatment symptomatic. To remove the drug from the blood, you can use hemodialysis.There is no specific antidote to the drug.

    Interaction:

    Pharmaceutically incompatible with other medicines.

    Simultaneous use of antipsychotics, analgesics and antidepressants can reduce the convulsive threshold, increasing the risk of seizures associated with the use of radiopaque. If possible, treatment with these drugs should be discontinued at least 48 hours before the procedure and not resumed earlier than 12 hours after the end of the procedure.

    In patients with diabetic nephropathy who take biguanides (metformin), with the introduction of radiopaque means, the development of lactic acidosis is possible. To prevent this complication, you should stop taking biguanides 48 hours before the procedure. To resume the administration of biguanides, you should ensure that there is no impairment of kidney function.

    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis when using yopamidol can be atypical and mistaken for vagal reactions.

    Patients who took less than 2 weeks of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

    Special instructions:

    General information

    Premises in which procedures are performed using radiocontrast preparations should be provided with equipment and medicines that are needed in emergency situations (oxygen cylinders, antihistamines and vasoconstrictors, glucocorticoid drugs).

    The radiopaque solution is poured into the syringe or the drip bottle immediately before the procedure. The radiopaque solution is intended for single use only. Rubber plug pierced only once, the remainder of the substance is destroyed.

    Preparation of the patient and the procedure for administering the drug

    Before each use of radiopaque means, it is necessary to obtain accurate information about the patient, including laboratory and instrumental research data (for example, serum creatinine, ECG, history of allergy, pregnancy).

    Prior to the study, the patient should eliminate disturbances in the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.This is especially true for patients with diabetes mellitus, polyuria, oliguria or gout, as well as newborns, infants and young children, elderly patients.

    Two hours before the procedure, the patient should stop eating.

    Radiopaque substance is heated to body temperature.

    When the drug is administered, the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, the patient is monitored physically, since most reactions occur precisely during this period.

    It is not recommended to perform preliminary testing of individual sensitivity using small doses of the drug due to the risk of severe hypersensitivity reactions.

    To provide immediate assistance in case of acute adverse reactions, safe access to the vessel (permanent cannula) should be ensured. The funds required in these cases must be available.

    Patients who are afraid of the procedure need premedication with sedatives.

    It is forbidden to mix radiopaque drug with other drugs in one syringe.

    The drug distorts the results of radioisotope studies of the thyroid gland (iodine binding capacity of the thyroid tissue remains reduced within 2 weeks after the administration of the drug).

    Before the study, the patient should eliminate disturbances in the water-electrolyte balance and provide adequate hydration, especially in patients with diabetes mellitus, as well as in newborns, infants, young children and the elderly patients.

    The open vial should be used immediately. Any remnants of the contrast agent should be discarded. Avoid using equipment in which the preparation can come into direct contact with a metal surface containing copper ions.

    When examining small children, one should not limit their intake of fluids before the introduction of hypertonic radiopaque solution, while any imbalance of water and electrolytes should be monitored.

    In pregnant women and patients with thyrotoxicosis, an iodine-containing radiopaque medium should be used only if absolutely necessary.

    It should be borne in mind,that the seizure of iodine in the thyroid gland will decrease within a few days (and sometimes 2 weeks) after the application of the iodine-containing radiopaque medium.

    Effect on the ability to drive transp. cf. and fur:

    After application of the drug in rare cases, it is possible to slow the speed of the psychomotor reaction. Avoid the management of vehicles and work with mechanisms within 24 hours after the administration of the drug.

    Form release / dosage:

    Solution for intravascular injection, 300 mg iodine / ml.

    Packaging:

    To 50, 100, 200, 500 ml in bottles of hydrolytic colorless glass type II.

    The bottle is sealed with a cork made of bromobutyl rubber, covered with an aluminum cap, on which a plastic cover is fixed.

    1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    In a place protected from light and X-rays, in the original package, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015511 / 01
    Date of registration:13.05.2009
    The owner of the registration certificate:Sanochemistry Pharmaceuticals AGSanochemistry Pharmaceuticals AG Austria
    Manufacturer: & nbsp
    Representation: & nbspPharmcomplex, Open CompanyPharmcomplex, Open CompanyRussia
    Information update date: & nbsp12.11.2015
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